GERATHERM Desktop 2.0 GT-6630 Gebrauchsanweisung Seite 206

‫ﺟﻤﻴﻊ ﺣﻘﻮﻕ ﺇﺩﺧﺎﻝ ﺗﻐﻴﻴﺮﺍﺕ ﻋﻠﻰ ﺍﳌﻮﺍﺻﻔﺎﺕ ﺍﻟﻔﻨﻴﺔ‬
‫ ﻣﻌﺘﻤﺪﺓ ﻭﻓﻘ ﹰ ﺎ ﻟﻠﻤﻮﺍﺻﻔﺔ‬Geratherm
‫ ﻭﻫﻲ ﻣﺨﻮﻟﺔ‬EN ISO 13485‫ ﻭ‬EWG/93/42 ‫ﺍﻟﻔﻨﻴﺔ‬
‫)ﺍﳌﻜﺎﻥ‬
TÜV Rheinland LGA Products ‫ﺍﳌﺬﻛﻮﺭ: ﺷﺮﻛﺔ‬
EN 60601- ‫• ﺷﺮﻭﻁ ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻘﻴﺎﺳﻴﺔ ﻟﻠﻨﻮﺭﻡ‬
‫ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ ﺍﻟﻮﻇﺎﺋﻒ‬
– ‫ ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ‬IEC/EN 60601-1-11 •
‫ﺍﻟﺠﺰﺀ 11-1: ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ‬
‫ﺍﻟﻮﻇﺎﺋﻒ ﺍﻟﺮﺋﻴﺴﻴﺔ.- ﻣﻌﺎﻳﻴﺮ ﺗﻜﻤﻴﻠﻴﺔ: ﺍﻟﻤﺘﻄﻠﺒﺎﺕ‬
‫ﺍﻟﻤﻔﺮﻭﺽ ﺗﻮﻓﺮﻫﺎ ﻓﻲ ﺍﻷﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ‬
.‫ﻭﺍﻟﻨﻈﻢ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻟﻼﺳﺘﺨﺪﺍﻣﺎﺕ ﺍﻟﻤﻨﺰﻟﻴﺔ‬
:1 ‫ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ‬
‫ﻳﺤﻘﻖ ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ‬
:2 ‫ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ‬
‫ﻳﺤﻘﻖ ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ‬
AR
.‫ﺑﻐﺮﺽ ﲢﺴﲔ ﺟﻮﺩﺓ ﺍﳌﻨﺘﺞ ﻣﺤﻔﻮﻇﺔ‬
‫ﻟﺘﺮﻛﻴﺐ ﺍﳌﻨﺘﺠﺎﺕ ﺍﻟﺘﻲ ﲢﻤﻞ ﺍﻟﻌﻼﻣﺔ‬
:1 ‫+ 1 ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ – ﺍﻟﺠﺰﺀ‬A1
DIN EN ISO 81060-1 ‫• ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ‬
DIN EN ISO 81060-2 ‫• ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ‬
‫ ﺃﺟﻬﺰﺓ‬EN 1060-3 ‫• ﻣﻌﻴﺎﺭ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻲ‬
:3 ‫ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ‬
‫ﻣﻠﺤﻖ ﺑﻤﺘﻄﻠﺒﺎﺕ ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ‬
‫ﺍﳌﻮﺍﺻﻔﺎﺕ ﺍﻟﻔﻨﻴﺔ‬
.(‫ﻟﻠﻤﻨﺘﺠﺎﺕ ﺍﻟﻄﺒﻴﺔ، ﺵ.ﺫ.ﻡ.ﻡ‬
‫ﺷﺎﺷﺔ ﻗﻴﺎﺱ ﺍﻟﻀﻐﻂ ﺗﺤﻘﻖ‬
(ISO 81060-1) ‫ﺍﻟﻤ ﹸ ﺆ ﹶ ﺗ ﹾ ﻤ ﹶ ﺘ ﹶ ﺔ‬
(ISO 81060-2) ‫ﺍﻟﻤﺆﺗﻤﺘﺔ‬
‫ﺍﻹﻟﻜﺘﺮﺭﻭﻣﻐﻨﺎﻃﻴﺴﻴﺔ‬
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